U-CLIP DEVICE, MODELS B140, B160 AND B180

K053252 · Medtronic Vascular · FZP · Dec 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K053252
• Device Name: U-CLIP DEVICE, MODELS B140, B160 AND B180
• Applicant: Medtronic Vascular
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The U-CLIP™ Device is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures.

Device Story

U-CLIP is a self-closing implantable clip used for tissue and prosthetic material approximation, attachment, or ligation, including vascular anastomosis and coronary artery bypass grafting. Device consists of a self-closing Nitinol clip connected to surgical needles via flexible members; features a Nitinol wire coil surrounding a Nitinol wire core. Design facilitates precise placement prior to closure and enables an interrupted suture technique, eliminating manual knot tying. Used by surgeons in endoscopic or non-endoscopic procedures. Provides mechanical closure of tissues or vessels; benefits patient by reducing procedural time and complexity associated with traditional suturing.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed functional characteristics, including clip strength and tissue drag forces, are equivalent to predicate devices. No clinical data provided.

Technological Characteristics

Implantable clip manufactured from implantable grade Nitinol. Features self-closing Nitinol wire coil surrounding a Nitinol wire core. Dimensions vary by model (B140, B160, B180). Mechanical actuation via self-closing design.

Indications for Use

Indicated for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation, attachment, or ligation, and creation of anastomosis in blood vessels, grafts, and other tubular structures. Contraindicated for tubal ligation.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Coalescent Surgical U-CLIP (K024366)
• Coalescent Surgical U-CLIP (K031623)
• Coalescent Surgical U-CLIP (K023125)
• Coalescent Surgical U-CLIP (K021407)
• Coalescent Surgical U-CLIP (K013664)
• Coalescent Surgical U-CLIP (K012317)
• Coalescent Surgical U-CLIP (K994160)
• Coalescent Surgical U-CLIP (K971588)

Submission Summary (Full Text)

{0}------------------------------------------------

053252 p. 1 of 2

U-CLIP™ Devices, Models B140, B160 & B180

# 510(k) SUMMARY of Safety and Effectiveness

### t. Applicant Information:

AND IN FORM AN A LA FOR AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN

要

| Date Prepared: | November 18, 2005 |
|-----------------------------------|-----------------------------------------------------------------------|
| Submitter: | Medtronic. Inc. |
| Address: | 710 Medtronic Parkway, NE<br>Minneapolis, MN 55432-5604 |
| Establishment<br>Registration No. | 2135394 |
| Contact Person: | David D. Cox, Ph.D.<br>Senior Principal Regulatory Affairs Specialist |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information: 11.

| Trade Name: | U-CLIP™ |
|--------------|------------------|
| Common Name: | Implantable clip |

| Classification Name: | Clip, Implantable |
|----------------------|---------------------------|
| Classification: | Class II, 21 CFR 878.4300 |
| Product Code: | FZP |

- Coalescent Surgical U-CLIP™ Predicate Device: 510(k) No. K024366, Reg. No. 878.4300; Product Code: FZP
Device Intended Use: The Surgical U-CLIP" is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.

{1}------------------------------------------------

053252-q.2of2

U-CLIP™ Devices, Models B140, B160 & B180

- The U-CLIP™ device is a self-closing clip for anastomosis and Device Description: tissue and prosthetic material approximation or attachment applications. The U-CLIP" consists of a self-closing Nitinol clip connected to surgical needles via flexible members. These U-CLIPs'" include a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.
- The U-CLIP™ Device is intended for endoscopic and non-Intended Use: endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures.

Do not use for tubal ligation. Contraindications:

Comparison to

- The Medtronic U-CLIP" devices are substantially equivalent to Predicate Device(s): the Coalescent Surgical U-CLIP™ K031623. K024366. K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new sizes are a line extension of larger sized clips.
- Verification and validation testing confirms that functional Test Data: characteristics are substantially equivalent to the predicate device cited. This included clip strength and tissue drag forces. All test data obtained satisfied the documented product and performance specifications.
- Based upon the technical information, intended use, in vitro, in Summary: vivo, and clinical performance information provided in previous pre-market notifications, the U-CLIPs" included in this submission have been shown to be substantially equivalent to currently marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from the body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2005

Mr. David D. Cox, Ph.D. MIT. Da Principal Regulatory Affairs Specialist Medtronic - Cardiac Surgery 7601 Northland Drive Brooklyn Park, Minesota 55423-1088

Re: K053252

K053252
Trade/Device Name: U-Clip Device, Models B140, B160 and B180 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: FZP Dated: November 18, 2005 Received: November 21, 2005

Dear Dr. Cox:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQK) prematic in substantially equivalent (for the indications
referenced above and have determined the device substantially equivalent in int referenced above and have detellinged the devices marketed in interstate for use stated in the enclosure) to regally inanced be of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the experieines of the Federal Fo commerce prior to May 28, 1976, the enactiven and of the Federal Food. Drug, devices that have been reclassined in accordance was as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvations provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of the You may, therefore, market the device, subject to the general registration, listing of
general controls provisions of the Act include requirements for annual misbranding and general controls provisions of the Act mender requirements as answer misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
If your device is classified (see above) mits entire) and in the major regulations affecting your device can
may be subject to such additional controls. Existing major regul may be subject to such additions: Existing major regals be found in the Code of I ederal Regalancial, your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substination with other requirements of the Act
that FDA has made a determination that your device of the Featurements You must that I'DA has made a determination nial your aceres on ofher Federal agencies. You must or any Federal statutes and regulations administer of only intel to: registration and listing (2)
comply with all the Act's requirements, including, but not programents as se comply with all the Act s requirements, mendant, our not turing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requiremen CFR Part 807); labeling (21 CFR Part 601); good manara20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable forth in the quality systems (QS) regulation (DP OF the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

## Page 2 - Dr. Cox

This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and Children The TRACT disconferential aquivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA indine of substantial equivalevice and t premarket notification. The FDA finding of substanted by of the subserned to your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rstiled. If you desire specific advice for your device on our nooming the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation of contact the Office of Compliance at (240) 270-01-2707 Pat 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarkst nouthcation " (21 Cr Cr Cr Cr Cr Cr Cr Crem (1) 1)
other general information on your responsibilities under the Act from the Division o other general information on your responsibilities unmber [phone] or
Manufacturers, International and Consumer Assistance at its toll-frees .html. Manufacturers, International and Consumer Assistance at 13 con 115 consert/industry/support/index.html.

Sincerely yours,

Barbara Buelum
fo

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Kos 3252 P. I

## Indications for Use

510(k) Number (if known):

U-CLIP Device Name:

Indications for Use:

The U-CLIP™ Device is intended for endoscopic and non-endoscopic The U-CLif - Device 15 intended for otterial approximation/attachment general soft tissue and prosthetion material upper in blood vessels, grafts and other tubular structures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sarbin Buchino for mkm
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_k053252